Omnicom, one of the world’s largest advertising firms, pays $20 million for part-ownership of Scirex, a research firm that conducts clinical studies on drugs to determine their effectiveness and safety. Thomas L. Harrison, a top executive of the company, says he expects Scirex’s studies to provide positive results for its clients in the drug industry. “Our goal is to help ensure that all clinical studies and each patient accrued into a study can be assessed to support the NDA submission.” [New York Times, 11/22/2002]

A federal jury in Portland, Oregon, finds in favor of the plaintiffs in the lawsuit Planned Parenthood v. ACLA (see 1996). The jury orders the American Coalition of Life Activists (ACLA—see July 1993) to pay $109 million in damages to the abortion providers and organizations who brought the suit; Judge Robert Jones declares that the ACLA’s campaign of published threats against the providers is “a blatant and illegal communication of true threats to kill, assault, or do bodily harm.” He issues an injuction against further publication of such threats (see 1996). In 2001, an appeals court will reverse the verdict on First Amendment grounds; a year later, a higher court will reaffirm the original verdict. [Ms. Magazine, 12/2002]

Merck begins the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, involving more than 8,076 subjects. The study is being carried out by a data and safety monitoring board (DSMB) that has been appointed by Merck. The Food and Drug Administration recommends the use of DSMBs but does not require them, nor does it require that the panels are put together by an independent party. Merck appoints Michael Weinblatt of Brigham & Women’s Hospital in Boston to lead the study. Weinblatt’s wife owns $73,000 in Merck stock, which according to doctors consulted by an NPR investigation, is enough to potentially influence Weinblatt’s judgment. Furthermore, during the course of the study, all the panel’s meetings will be attended by Merck employee Deborah Shapiro, who is present even during the panel’s private deliberations. She is also the notetaker for the meetings. [National Public Radio, 6/8/2006] The VIGOR study is the largest clinical trial ever performed for the drug. Half the participants is given Vioxx, while the other half is given naproxen. The study is designed to determine whether Vioxx causes fewer digestive problems than naproxen, an older painkiller. The outcome of this study is important to Merck because Vioxx’s expected characteristic of being gentler on the stomach would be the drug’s only selling point since there is no evidence that it is a better painkiller than other drugs. The FDA currently requires Vioxx to have the same warning about gastrointestinal bleeding that is carried on the Naproxen label. [USA Today, 10/12/2004; CBS News, 4/28/2005; National Public Radio, 6/8/2006]

Anti-abortion advocate Michael Bray (see September 1994), serving four years for conspiracy in firebombing 10 abortion clinics in Virginia, Maryland, and the District of Columbia, tells a CBS reporter, “I consider blowing up a place where babies are killed a justifiable act.” Bray is a Lutheran minister. [Feminist Women's Health Center News, 2010]

The Food and Drug Administration approves Vioxx as a treatment for acute pain, dysmenorrhea, and osteoarthritis in adults, making the drug the second Cox-2 inhibitor available by prescription in the United States. [US Food and Drug Administration, 2005]

Based on the recent lawsuit by the National Organization for Women (see April 20, 1998), District Judge David Coar issues a nationwide injunction against the anti-abortion advocates who lost the case. Coar’s injunction forbids the defendants from hindering the right of women to obtain reproductive health services at clinics and the right of the clinics to provide those services. One of the defendants, Joseph Scheidler, will appeal the ruling on several grounds, including the First Amendment right of free speech. [National Organization for Women, 9/2002]

The VIGOR study’s safety panel has its first meeting. VIGOR, or the Vioxx Gastrointestinal Outcomes Research study, was designed to determine whether Vioxx causes fewer stomach problems than other painkillers on the market (see January 1999). Results as of October 1, 1999 suggest that patients taking Vioxx experience fewer ulcers and less gastrointestinal bleeding than those taking naproxen. [National Public Radio, 6/8/2006]

At the VIGOR safety panel’s second meeting (see also January 1999 and October 3 or 4, 1999), panel members discuss concerns over the “excess deaths and cardiovascular adverse experiences” observed among patients taking Vioxx. [US Food and Drug Administration, 2/1/2001, pp. 5 ] As of November 1, 1999, 79 patients out of the 4,000 taking the drug have experienced serious heart problems or have died, compared with 41 patients taking naproxen. Minutes of the meeting note that “while the trends are disconcerting, the numbers of events are small.” [National Public Radio, 6/8/2006]

The VIGOR study’s safety panel meets for a third time and learns that as of December 1, 1999, the number of Vioxx patients who have experienced heart problems or have died is twice as high as those taking naproxen. The panelists are shown a chart with two lines—one showing the number of deaths in the Vioxx group; the other, deaths in the naproxen group. The chart shows that since the sixth week of the study, the line representing the Vioxx group has been going up at an increasingly brisk pace, while the naproxen group’s line rises slower and is relatively linear. [National Public Radio, 6/8/2006] Some members suggest that diverging lines could be “due to cardioprotective effects of Treatment B,” i.e., that naproxen is somehow reducing the risk of heart problems. [US Food and Drug Administration, 2/1/2001, pp. 6 ] The panel’s chairman, Michael Weinblatt, and Merck statistician Deborah Shapiro write a letter to Merck’s Alise Reicin advising that the company develop a plan to study the cardiovascular results before the VIGOR study is completed. When an investigation by NPR learns about this meeting, it asks three experts to comment on the chart and the panel’s decision. All three say that the study should have been called off immediately because the chart clearly showed that the risk of heart problems among those taking Vioxx increased with time. The panel, in a statement to NPR, claims that it did not cancel the study noting that it was not clear to the panelists at the time whether the different rates of heart problems and deaths were a result of Vioxx causing the cardiovascular problems, or naproxen preventing them. But no study has ever proven that naproxen is cardioprotective. [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

Merck says it does not want to begin developing a plan to analyze the data on the large number of deaths from heart problems that has occurred during a clinical trial for its drug Vioxx (see December 22, 1999 and November 18, 1999). Michael Weinblatt, who is heading the study, sent a request to Merck the month before asking the company to develop such a plan (see December 22, 1999). Merck suggests that they wait and combine the cardiovascular results of this study with the results from other clinical studies for the drug. But Weinblatt is adamant that the company needs to begin analyzing the data immediately, and continues discussing the matter with Merck, which finally agrees to a plan the following month (see Early February 2000). [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

The VIGOR study, a clinical trial for the drug Vioxx, comes to an end (see also January 1999). The goal of the study was to determine whether patients taking Vioxx experienced fewer gastrointestinal problems than subjects taking naproxen, another painkiller. The study’s results back Merck’s claim that Vioxx is gentler on the stomach. But it also seems to confirm the suspicions of some Merck scientists that it causes cardiovascular problems (see November 18, 1999 and December 22, 1999). During the course of the 12-month study, 20 of the patients taking Vioxx died, far more than the number of deaths among the group taking naproxen. [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006] Later analyses of the data from the study find that subjects taking Vioxx were five times more likely to suffer a heart attack. [CBS News, 4/28/2005]

Edward Scolnick, head of Merck’s research labs, sends an e-mail to his colleagues noting that Vioxx’s anticipated cardiovascular side effects “are clearly there… It is a shame but it is a low incidence and it is mechanism based as we worried that it was.” [Wall Street Journal, 11/1/2004; HeartWire, 11/1/2004]

Merck issues a press release announcing the results of the VIGOR study (see March 2000) and saying that the study showed patients taking Vioxx experienced fewer gastrointestinal problems than patients on naproxen. Merck also says that “significantly fewer thromboembolic events were observed in patients taking naproxen.” Merck asserts that this was due to “naproxen’s ability to block platelet aggregation,” [Merck, 3/27/2000] a theory for which there is no conclusive evidence. [New York Times, 5/22/2001]

According to an internal company document, Merck research chief Edward Scolnick discusses possible plans to reformulate Vioxx with the company’s in-house patent counsel. The new Vioxx would contain an anti-clotting agent to reduce the risk of cardiovascular problems. The document indicates that the company’s researchers believe the current Vioxx formula inhibits the production of a substance called prostacyclin which leads to blood vessel constriction and clotting. But Merck was alerted to this problem two years before by scientist Garrett FitzGerald, who had warned the company that all Cox-2 inhibitors would likely have this effect. Merck, eager to get its drug on the market, dismissed his research (see 1998). [Associated Press, 6/22/2005]

Merck sends all of its sales representatives a “Cardiovascular Card,” a tri-fold pamphlet on the safety of Vioxx, so they “are well prepared to respond to questions about the cardiovascular effects of Vioxx.” Since the announcement (see March 27, 2000) of the VIGOR study results, physicians have been asking the representatives whether Vioxx causes heart problems. The pamphlet contains a table of data appearing to indicate that patients on Vioxx are 11 times less likely to die than patients on standard anti-inflammatory drugs, and 8 times less likely to die from heart attacks and strokes. Another section displays data showing that Vioxx patients are half as likely to suffer heart attacks as patients who receive a placebo. The risk for patients on other anti-inflammatory drugs appears to be identical. [Merck, 4/28/2000 ] But the pamphlet is based on the combined data of several disparate studies, conducted before the drug’s approval. None of the studies were designed to test the cardiovascular safety of the drug. An FDA medical reviewer later tells the staff of a congressional committee that the relevance of those studies to the question of Vioxx’s effects on the heart is “nonexistent.” Furthermore, the reviewer says it would be “ridiculous” and “scientifically inappropriate” to use the pamphlet as evidence of the drug’s safety. [Office of Representative Henry A. Waxman, 5/5/2005, pp. 16-19 ]

Merck submits the results of the VIGOR clinical trial for its drug Vioxx to the New England Journal of Medicine (NEJM) for publication. The data include only 17 of the 20 deaths that occurred among patients taking Vioxx (see March 2000). [National Public Radio, 6/8/2006] Data concerning the last three deaths were deleted two days before, according to Dr. Gregory Curfman, executive editor of the journal, who does not discover the missing data until December 2004. “When you hover the cursor over the editing changes, the identity of the editor pops up, and it just says ‘Merck,’” Curfman later tells Forbes magazine. [Forbes, 12/8/2005]

The authors of a paper on VIGOR, a clinical study on the drug Vioxx, submit two sets of corrections to the New England Journal of Science for the manuscript they submitted in May (see May 18, 2000). They do not correct the omission of three fatal heart attacks that occurred toward the end of the study (see March 2000) after a February 10 “cut-off” date (see Early February 2000). [National Public Radio, 6/8/2006]

In a memo to Merck scientist Alise Reicin, Merck statistician Deborah Shapiro includes a reference to the three Vioxx deaths that occurred during the last month of the VIGOR study (see March 2000). Those three deaths—numbers 18, 19, and 20—were not included in a paper submitted to the New England Journal of Medicine in which Reicin and Shapiro are listed as authors (see May 18, 2000). [National Public Radio, 6/8/2006]

Merck informs the FDA about three fatal heart attacks (deaths 18, 19, and 20) that occurred toward the end of VIGOR, the clinical trial for its drug Vioxx that ended last March (see March 2000). These three deaths were initially left out because they had taken place after a February 10 “cut-off” that had been set at the company’s insistence (see Early February 2000) [National Public Radio, 6/8/2006]

The New England Journal of Medicine publishes the VIGOR paper (see May 18, 2000) summarizing the results of a clinical trial for the drug Vioxx. The paper’s main conclusion is that patients taking the drug experienced fewer gastrointestinal complications than patients taking naproxen, another painkiller. This conclusion is important to Merck, the maker of the drug, because this is Vioxx’s only selling point. There is no evidence that Vioxx is a more effective painkiller than any other drug available on the market. But the paper’s section on “General Safety” is misleading because the authors leave out the deaths of three Vioxx patients (see March 2000). The authors were aware of the fatal heart attacks and had at least two opportunities to correct these omissions (see July 2000-November 2000). Notwithstanding their knowledge of these deaths, the authors say there is no causal relationship between Vioxx and heart problems. [Bombardier et al., 2000; National Public Radio, 6/8/2006] When the Journal learns about the missing deaths, executive editor Dr. Gregory Curfman, demands a correction. He tells Forbes magazine, “I was somewhere between surprised and stunned. They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health.” [Forbes, 12/8/2005]

HCA Inc., the largest for-profit hospital chain in the US, reaches a settlement with the Justice Department over allegations of having defrauded the government. HCA is owned by the family of Senate majority leader Bill Frist. As part of the agreement, the company pleads guilty to 14 criminal counts and agrees to pay more than $840 million in criminal fines, civil penalties, and damages. It is the largest fraud settlement in US history. The Justice Department’s investigation found that the company had employed a variety of schemes to falsely charge or overcharge for services provided to patients covered by federal health plans. HCA billed Medicare, Medicaid, and other federal health care programs for lab tests that were not medically necessary or ordered by physicians. It billed the government for non-reimbursable expenses by disguising them as reimbursable “community education” expenses or as “management fees.” Other violations included using incorrect diagnostic codes when billing the government in order to increase its revenue, billing for services rendered to patients who did not qualify to receive them, and billing for services that were never performed. Of the total amount settled upon, $95 million is for violations committed by two HCA subsidiaries, Columbia Homecare Group Inc. and Columbia Management Companies Inc. The two companies had engaged in cost report fraud, fraudulent billing, paying kickbacks to doctors for referrals, and paying kickbacks in connection with the purchase and sale of home health agencies. [CBS News, 12/14/2000; US Department of Justice, 12/14/2002] Not all of the Justice Department’s allegations are resolved in the settlement. In spring 2003, HCA will reach another settlement over allegations of fraudulent cost reporting and kickbacks to physicians for referrals (see June 26, 2003).

Merck’s sales force develops a flash-card game called “Dodge Ball Vioxx” to help train Merck sales representatives on how to respond to certain questions and concerns that doctors might have about Vioxx. [Daily Journal Extra, 1/31/2005] The game includes a 12-page list of obstacles including some questions concerning the association between Vioxx and heart problems. One of them is, “I am concerned about the cardiovascular effects of Vioxx.” In the summer of 2005, a former Merck sales woman tells CBS 60 Minutes that when faced with that question, the company said representatives should say the drug does not cause heart problems. “We were supposed to tell the physician that Vioxx did not cause cardiovascular events; that instead, in the studies, Naproxen has aspirin-like characteristics which made Naproxen a heart-protecting type of drug where Vioxx did not have that heart-protecting side,” she said. According to the FDA, there is no evidence that Naproxen has such properties. [CBS News, 4/28/2005]

Merck files a patent application with the US Patent Office for a drug that would contain a combination of Vioxx and an anti-clotting agent, or thromboxane inhibitor. The new drug would hopefully reduce the risk of cardiovascular problems while preserving Vioxx’s gastrointestinal benefits. Merck never develops the drug. Critics later note that Merck’s interest in this new drug contradicted its assertions that Vioxx was safe for the heart. [Associated Press, 6/22/2005]

Fearing increased public concern over the safety of Vioxx, Merck sends its sales representatives a bulletin instructing them in all capital letters: “Do not initiate discussions on the FDA Arthritis Advisory Committee… or the results of the… VIGOR study.” The previous day, an FDA panel (see February 8, 2001) reviewed the results of the VIGOR study and said physicians need to be informed that Vioxx appears to cause “an excess of cardiovascular events in comparison to naproxen.” The Merck bulletin provides a list of responses that its representatives are authorized to use in addressing physicians’ concerns. It emphasizes that these are the only responses they are allowed to use. If doctors ask about Vioxx’s effects on the heart, sales persons should say, “Because the study is not in the label, I cannot discuss the study with you.” However, as a report by Henry A. Waxman notes, drug company representatives are permitted by FDA regulations to discuss safety concerns even when those concerns are not on the label. The sales persons are also advised to tell physicians to submit their questions in writing to Merck’s medical services department. Merck says reps can also show the physicians the Cardiovascular Card, a pamphlet consisting of data that appears to show that Vioxx is safe (see April 28, 2000). The bulletin indicates that sales reps are not supposed to leave the pamphlet with the doctor. [Merck, 2/9/2001 ; Office of Representative Henry A. Waxman, 5/5/2005, pp. 22 ]

A new Merck training manual instructs company sales representives on how to use reprints of medical journal articles in their sales pitches to doctors. The company has divided the reprints into two categories, “approved” and “background.” The “approved” category includes articles that “provide solid evidence as to why [doctors] should prescribe Merck products for their appropriate patients.” Only these articles can be used or cited by Merck sales people. Background articles, on the other hand, cannot be used or even referenced. Doing so would be “a clear violation of Company Policy,” the document says. If a physician has any questions about studies not in the “approved” category, the sales representive should refer the individual to Merck’s medical services department. [Merck, 3/2001 ; Office of Representative Henry A. Waxman, 5/5/2005, pp. 12-13 ]

The Christian Defense Coalition (CDC) urges the Bush administration to show “restraint” in its handling of the arrest of accused murderer James Kopp, whose anti-abortion beliefs triggered his shooting of Dr. Barnett Slepian (see March 29, 2001). The CDC says that the “vast majority of the pro-life community” condemns violence against abortion doctors such as Slepian, and urges Attorney General John Ashcroft and the Department of Justice “not to use this episode to harass and intimidate the pro-life movement as the Clinton administration did” (see May 1994 and January 1996), and makes the same request of pro-choice organizations. The CDC also urges the general public to remember that Kopp is “innocent until proven guilty.” [Christian Defense Coalition, 3/29/2001]

Televangelist Pat Robertson, the head of the Christian Coalition and a former Republican presidential candidate, says that while he is staunchly opposed to abortion, he believes that China’s one-child policy, which he seems to think includes forcible abortions for families with more than one child, is acceptable. Robertson, who has admitted to having extensive personal business interests in China, says that nation suffers from “tremendous unemployment” and is plagued with “antiquated factories” owned by the government “that will have to be shut down, spawning more loss of jobs.… So, I think that right now they are doing what they have to do. I don’t agree with forced abortion, but I don’t think the United States needs to interfere with what they’re doing internally in this regard.” Robertson adds that the Chinese are “courting a demographic catastrophe” by aborting more girls than boys, and speculates that in 10 or 20 years Chinese men will have to import wives from Indonesia, which “will, in a sense, dilute the—what they consider the racial purity of the Han Chinese.” [Feminist Women's Health Center News, 2010]

In a 7 to 3 vote, an FDA advisory panel recommends approving the antibiotic Ketek, also known as telithromycin, for use in treating streptococcus pneumonia. But the panel does not recommend approving it for use against acute chronic bronchitis, sinusitis, or penicillin-resistant or erythromycin-resistant strep. The panel also recommends conducting additional clinical trials to “see if hints of concern… are real or not” about the drug’s potential side affects on the heart and liver. [Associated Press, 4/26/2001]

The New York Times reports the results of the VIGOR study (see March 2000), which showed that Vioxx, marketed by Merck, increases the risk of heart attacks four-fold (later studies increase this to five-fold). The Times also reports Merck’s interpretation of the results—that the different number of heart attacks suffered by patients taking Vioxx compared to those using naproxen was due to the heart-protective properties of naproxen. But no studies have been done showing that naproxen prevents heart attacks, says Dr. Maria Lourdes Villalba, an FDA scientist who was interviewed by the newspaper. Another scientist, Dr. M. Michael Wolfe, chief of the gastroenterology section at the Boston University School of Medicine, says people need to know about these risks. “The marketing of these drugs is unbelievable. I’m sure there are many people out there who are taking these drugs that should not be,” he says. Another concern noted is that the very same people who are likely to take the drug—elderly people with arthritis—are the ones with the highest risk of having heart problems. [New York Times, 5/22/2001]

Merck issues a press release titled “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx” asserting that there is no evidence that patients taking the prescribed dosage levels of Vioxx have an increased risk of having heart problems. It says that the higher number of heart troubles experienced by patients taking Vioxx compared to naproxen during the VIGOR study (see March 2000) was likely because naproxen has similar properties to aspirin, which is known to prevent heart attacks. [Merck, 5/22/2001] The FDA later issues a warning to Merck calling this press release “simply incomprehensible, given the rate of MI and serious cardiovascular events compared to naproxen” (see September 17, 2001). [US Food and Drug Administration, 9/17/2001, pp. 1-2 ]

The same day the New York Times publishes an article (see May 22, 2001) raising questions about the safety of Vioxx, Merck sends a bulletin to its sales representatives instructing them in capital letters: “Do not initiate discussions on the results of the… VIGOR study, or any of the recent articles in the press on Vioxx.” The bulletin says that if physicians ask any questions about the cardiovascular safety of Vioxx, sales reps should refer to the “Cardiovascular Card” (a marketing pamphlet on the safety of Vioxx, see April 28, 2000), request that Merck’s “Medical Services” staff fax or Fedex additional information to the doctor, or respond appropriately “in accordance with the obstacle-handling guide.” [Merck, 5/22/2001 ]

Thomas A. Scully is sworn in as head of the Health Care Financing Administration (HCFA), a division of the US Department of Health and Human Services. Prior to joining the Bush administration, Scully served as president and chief executive officer of the Federation of American Hospitals, a trade association that lobbies on behalf of 1,700 privately-owned and managed community hospitals and health systems. He held that position for six years [Healthcare Financial Management, 7/2001; US Department of Health and Human Services, 11/10/2003] and was making $675,000 a year when he left. As the administrator of HCFA, he will be paid a salary of $134,000 a year. [New York Times, 12/3/2003] During his confirmation hearings, Scully promised the Senate Finance Committee that he would “aggressively enforc[e] the fraud statutes.” Under the Clinton administration, the Justice Department had brought a number of lawsuits against hospitals alleging that they had over billed Medicare, Medicaid, and other federal heath programs. [Iglehart, 12/27/2001]

President Bush appoints Ann-Marie Lynch as deputy assistant secretary in the office of policy at the Department of Health and Human Services. [US Congress, 7/25/2002, pp. 86 ; Denver Post, 5/23/2004] One of Lynch’s responsibilities is to decide which topics are researched and which reports are released. She previously worked as a lobbyist for the drug- company trade group Pharmaceutical Research and Manufacturers of America where she fought congressional efforts to implement price controls on prescription drugs. She had argued that price caps would discourage medical innovation. [Denver Post, 5/23/2004] During her tenure at DHHS, Lynch’s division will publish a report praising brand-name drugs and warning that “restrictions on the coverage of new drugs could put the future of medical innovation at risk and may retard advances in treatment” (see July 2002). She will also block the release of several completed research reports that challenge drug-company claims (see (Between July 2001 and May 2004)).

The FDA informs Aventis that it will not approve the drug Ketek until the company has provided enough information to determine the drug’s safety profile. [Aventis, 6/4/2001] In April, an FDA advisory board recommended additional clinical studies for the drug because of concerns about potential side effects on the heart and liver (see April 26, 2001).

Ann-Marie Lynch, deputy assistant secretary in the office of policy at the Department of Health and Human Services, allegedly blocks the release of several government reports that contradict claims made by the drug industry. One of them is a 2001 report stating that involvement of private health companies in Medicare’s prescription-drug benefit programs would lead to higher prices and would not work well in rural areas. [Denver Post, 5/23/2004]

Thomas A. Scully, administrator of the Centers for Medicare & Medicaid Services (CMS), tells Congress that he believes only a third of the estimated $12 billion in improper payments to health care providers is fraudulent. He says “the rest is
probably billing mistakes.” Scully, a former lobbyist for the health industry, admits the inspector general would probably disagree with his estimate. [US Congress, 7/26/2001, pp. 27 ]

President Bush appoints Daniel E. Troy as the FDA’s chief counsel. [Financial Times, 8/14/2001] Before taking the position, Troy was a partner at the law firm Wiley Rein & Fielding, where he sued the FDA several times on behalf of drug companies, including pharmaceutical giant Pfizer. He has repeatedly argued that the agency has only limited authority to regulate drug companies. Troy is mostly known for his involvement in the landmark Supreme Court case that ruled the FDA does not have the authority to regulate tobacco. [Boston Globe, 12/22/2002; Denver Post, 5/23/2004] As chief counsel, Troy will help the FDA commissioner, a post that is currently vacant, to draft policy and enforcement provisions. The commissioner’s post will remain vacant until October 2002. So far, Bush has considered two people for the position—Michael Astrue, senior vice-president at Transkaryotic Therapies, a British biotech company, and Eve Slater, Merck’s senior vice-president. In both cases the Senate made it clear that their nominations would be rejected because of their involvement in FDA-regulated industries. [Financial Times, 8/14/2001]

An new analysis of data from the VIGOR study (a clinical trial for Vioxx, see January 1999) along with data from a clinical trial of the drug Celebrex, and two smaller studies, raises concerns that COX-2 inhibitors may cause cardiovascular events. The study, published in the Journal of the American Medical Association, concludes that “it is mandatory to conduct a trial specifically assessing cardiovascular risk and benefit of these agents.” The authors are cardiologists Debabrata Mukherjee, Steven Nissen, and Eric Topol. [Mukherjee, Nissen, and Topol, 2001; National Public Radio, 6/8/2006]

The Food and Drug Administration faxes a warning letter to Raymond Gilmartin, the CEO of Merck, accusing the company of conducting a deceptive promotional campaign for its drug Vioxx. The eight-page letter, referring mostly to events that took place between June 2000 and June 2001, states: “You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the VIOXX Gastrointestinal Outcomes Research (VIGOR) study (see March 2000), and thus, misrepresents the safety profile for VIOXX. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).… You assert that Vioxx does not increase the risk of MIs and that the VIGOR finding is consistent with naproxen’s ability to block platelet aggregation like aspirin. That is a possible explanation, but you fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence, and that there is another reasonable explanation, that Vioxx may have pro-thrombotic properties [i.e., cause heart attacks]. You have also engaged in promotional activities that minimize the Vioxx/Coumadin (warfarin) drug interaction, omit important risk information, make unsubstantiated superiority claims against other NSAIDS, and promote Vioxx for unapproved uses and an unapproved dosing regimen.… Your minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns.” The letter also warns the company about a May 2001 press release (see May 22, 2001), which claimed the drug has a “favorable cardiovascular safety profile.” [US Food and Drug Administration, 9/17/2001, pp. 1-2 ]

An expert panel convened by the National Science Academy’s Institute of Medicine issues a report recommending a number of changes to how the FDA regulates the drug industry. The proposed changes are unanimously endorsed by the panel, comprised of 15 experts from academic and professional organizations. Some of the recommendations include: The FDA should implement a moratorium on direct consumer advertising of recently approved classes of drugs until enough aggregate data is available to confirm the drugs’ safety. Packaging for such medications should have a special symbol imprinted on them alerting consumers to the higher risk associated with new medications. The FDA should be required to reevaluate the safety and effectiveness of drugs at least once every five years after the drug has been approved. The agency’s current system for monitoring drug safety post-approval is far less effective than pre-approval testing. The report notes that there is a history of fierce disagreements between the FDA’s Office of Drug Safety and the agency’s Office of New Drugs. The FDA should be given new powers to impose fines, injunctions, and withdrawals
when drug companies fail to complete the required safety studies. The agency should be given the authority to impose a wider range of restrictions on drugs it considers potentially unsafe. The government should require drug companies to register all clinical trials they sponsor in a government-run database so patients and physicians can review all studies. Currently, only those studies published in medical journals are accessible to the public, and these tend to be the studies that produce the most favorable results for the drug being tested. Expert advisory panels should not be loaded with industry-connected scientists. Most of the members making up these panels should be free of industry ties. “FDA’s credibility is its most crucial asset, and recent concerns about the independence of advisory committee members… have cast a shadow on the trustworthiness of the scientific advice received by the agency,” the report says. [Institute of Medicine, 9/22/2006; Washington Post, 9/23/2006; New York Times, 9/23/2006]

Aventis contracts Pharmaceutical Product Development, Inc. to do a clinical trial for Ketek, an antibiotic designed to treat respiratory infections. The trial, named “Study 3014,” is being done because of FDA concerns (see Early June 2001) about possible links to heart and liver problems. The company pays doctors $400 for each patient they enroll in the study. Some of the doctors—a bit overzealous in recruiting patients—forge signatures, sign up family members, and invite patients into the study who do not have infections. There are also problems with the way some of the doctors collect and record their data. One doctor, who enrolls 251 patients, does not follow the study’s instructions and fails to report adverse drug reactions. Another physician, Dr. Maria Anne Kirkman-Campbell, who runs a weight-loss clinic, signs up 407 patients—but only 10 percent of them actually take the drug. These problems are discovered by FDA inspectors in fall 2002. [ABC, 1/14/2006; Wall Street Journal, 5/1/2006 ]

The US Department of Health and Human Services implements a new policy requiring that all enforcement letters to drug companies potentially engaged in false advertising be pre-screened by FDA Chief Counsel Daniel E. Troy. Prior to the policy change, the FDA’s drug-marketing division and district offices were free to determine when an enforcement letter was warranted. After the policy change, the number of enforcement letters sent annually drops by two-thirds. [Boston Globe, 10/19/2002; Boston Globe, 12/22/2002; Denver Post, 5/23/2004] In October 2002, the General Accounting Office (GAO) finds that the FDA is taking so long to review the letters that “misleading advertisements may have completed their broadcast life cycle before FDA issued the letters.” [Boston Globe, 12/22/2002] Fifteen months later, another report by the GAO finds that the review process is still slow, with the average approval time being six months. [Boston Globe, 1/30/2004]

An appeals court rejects an argument by anti-abortion advocate Joseph Scheidler (see 1980 and 1986) that he should be allowed to continue his campaign of violence and intimidation towards women seeking abortions and other health services (see July 16, 1999). The Seventh Circuit Court of Appeals finds that “the First Amendment does not protect violent conduct” and that “violence in any form is the antithesis of reasoned discussion.” Scheidler and his colleagues will appeal to the Supreme Court. [National Organization for Women, 9/2002]

The Boston Globe reports that the FDA is considering the validity of the pharmaceutical industry’s argument that the agency’s regulation of drug advertisements violates manufacturers’ “free speech” rights. The inquiry is being led by FDA Chief Counsel Daniel E. Troy, who represented drug companies before being appointed to the FDA position in August 2001 (see August 2001). [Boston Globe, 10/19/2002]

Scores of family planning clinics in at least 12 states have received letters containing anthrax threats, according to officials of feminist and abortion-rights organizations. Eleanor Smeal of the Feminist Majority Foundation says that over 200 clinics and advocacy organizations received letters in early November, all delivered in Federal Express envelopes. The envelopes that were opened contained a suspicious white powder and letters signed by the Army of God (AOG), a violent anti-abortion group (see 1982). This was the second such mailing in recent weeks; the first mailing was comprised of some 280 letters containing threatening letters and white powder purporting to be anthrax. None of the powder in any of the envelopes contained real anthrax; the letters were apparently hoaxes. Some of the letters in the latest mailings said: “You’ve ignored our earlier warnings. You’ve been exposed to the real thing. High-quality.” Groups targeted by the mailings include the Feminist Majority Foundation, the Center for Reproductive Law and Policy, Catholics for a Free Choice, Advocates for Youth, and the American Association of University Women. The persons responsible for the mailings somehow obtained the account numbers of two pro-choice organizations, the Planned Parenthood Federation of America and the National Abortion Federation, and used those accounts to pay for the mailings. The mailings have been traced to at least three drop-off locations in Virginia and Philadelphia. More packages are believed to be en route, and Federal Express is trying to intercept them. “I think the people responsible are despicable,” says Vicki Saporta of the National Abortion Federation. “They actually used our account number and our address, so our members would feel comfortable opening them.” Gloria Feldt, president of the Planned Parenthood Federation of America, says: “These letters are designed to terrorize us, and disrupt our work and our lives. That’s terrorism, plain and simple, and we take it very seriously.… The fact that they would forge the names of our staff members to terrorize employees is truly evil. Their heinous activities will not succeed.” Brian Emanuelson of the Connecticut Department of Environmental Protection says, “These were intended to be a threat to scare people and we want to make sure this is not what they say it is.” [CBS News, 11/9/2001] The anthrax mailings were from anti-abortion activist and AOG member Clayton Waagner (see 1997-December 2001).

Mark Colombo, 57, is told by a heart specialist at Redding Medical Center in California, that he needs a double bypass surgery. When he asks a surgeon for a second opinion, he is told the problem is so severe that he shouldn’t go home until after it has been done. The following day, he undergoes surgery. But months later, a Sacramento cardiologist tells him the operation was probably not necessary. In 2004, Colombo, along with more than 769 other heart patients, will sue Tenet Healthcare Corp., which owns the hospital, and settle for $395 million (see December 21, 2004). The company had allegedly performed hundreds of unnecessary bypass surgeries and other medical procedures between 1992 and 2002. [San Francisco Chronicle, 12/22/2004]

Beginning no later than January 2002, Merck provides its sales staff with detailed information on the prescribing habits of individual doctors, or as they like to call them, “customers.” The data—purchased by Merck from an outside company—allows sales representatives to see how many prescriptions each of their customers writes for any given medication. The sales person can see which customers are prescribing large quantities of Merck drugs and which ones aren’t, indicating to the rep which customers need to be worked on the most. Furthermore, each doctor has a “Merck Potential,” which is a “dollar estimate of each prescriberÃÂ¢ÃÂÃÂs total prescribing volume that can realistically be converted to Merck prescriptions.” Bonuses for reps are based on the overall sales and Merck market shares for their respective sales territories. So the more Merck drugs their customers prescribe, the more money they make. [Merck, 1/2002 ; Office of Representative Henry A. Waxman, 5/5/2005, pp. 13-14 ]

A training manual for Merck’s marketing force recommends that sales representatives think of people like Helen Keller, Martin Luther King, Tiger Woods, and George Washington when they are faced with a doctor who is a hard sell. “Martin Luther King could have laid low when his home was firebombed,” the manual states, suggesting that like MLK, the Vioxx sales representatives should never back down. [Merck, 1/2002 ]

The Bush administration decides to drop its plan to nominate Dr. Alastair J. J. Wood as commissioner of the Food and Drug Administration. An article recently posted on the conservative National Review Online’s website warned that Wood is not friendly to industry interests. “The people I know in clinical pharmacology, in the research trenches, went berserk when they heard about Wood,” wrote Robert Goldberg, a senior fellow at New York’s Manhattan Institute, a free-market think tank. Goldberg said the doctor is overly obsessed with drug safety and asserts, falsely, that Wood is “a buddy of Senator Ted Kennedy.” The attack on Wood was continued in the editorial pages of the Wall Street Journal six days later in a piece titled “It’s Not Ted’s FDA.” Shortly after the publication of these articles, the White House calls Wood to inform him that the administration is no longer considering his nomination for commissioner, a post that has been vacant for more than a year. Republican Senator Bill Frist—the person who had recommended Wood’s nomination—tells the Boston Globe that the White House was concerned that Wood “put too much emphasis on the safety.” Wood’s track record was evidence that he might take an aggressive approach to regulating drugs. He previously called for an independent board to investigate potentially deadly drugs. The current policy is to allow the drug companies to do their own studies on adverse drug reactions and then provide these results to the FDA. Wood has also said that he believes the current FDA regulatory process has an inherent conflict of interest because the same department that approves drugs is also in charge of reviewing the safety of those drugs post-approval, a criticism that is shared by at least one FDA insider (see November 18, 2004). Furthermore, in May 2001, Wood supported making three allergy prescription drugs—Pfizer’s Zyrtec, Schering-Plough’s Claritin, and Aventis’s Allegra—available over-the-counter (OTC). The companies were opposed to the idea because OTC drugs are often sold at lower prices and are not typically covered by insurance. During a panel discussion on the issue, Wood had noted, “What we have today is an unseemly parade of people trying to protect their own financial interests.” [Boston Globe, 5/27/2002]

Mark Crutcher. [Source: Life Dynamics]Members of the anti-abortion organization Life Dynamics call Planned Parenthood clinics in 49 states, pretending to be teenaged girls pregnant by older men, and use the clinics’ promises of confidentiality to accuse them of covering up sexual abuse. The group secretly records telephone conversations with some 800 receptionists and staff members, and then uses selectively edited snippets of the taped conversations in a national publicity campaign against Planned Parenthood. The intent of the organization is to discredit Planned Parenthood and other abortion providers, and to encourage lawsuits against them, according to information published on the organization’s Web site. Life Dynamics, based in Denton, Texas, claims that the tapes are “evidence” that Planned Parenthood and other women’s clinics are complicit in child sex abuse. The organization’s founder, Mark Crutcher, releases a report called “Child Predators,” which is picked up by, among other news outlets, Newsday and Fox News. The organization’s evidence fails to hold up under scrutiny by law enforcement officials and media outlets, and pro-choice attorneys and advocates raise questions about the legality of Life Dynamics’s tactics. The organization bills itself as a “political marketing agency” whose stated goal is to prevent women from obtaining abortions, even if they are legally entitled to them. Crutcher and the group have previously attempted to claim that abortions cause breast cancer, and that Planned Parenthood trafficked in human body parts; both claims have been solidly debunked. Roger Evans of Planned Parenthood notes: “No one has an obligation to report or to conduct an inquisition based on a phone call, because you have no idea who is on the other end and what the truth is. And in this case, [the] Life Dynamics hoax caller was scrupulously careful not to give a name.” He goes on to say that law enforcement officials who have investigated the Life Dynamics charges “have been satisfied that people are conscientiously complying with the law as it’s written, and that people are reporting when kids are in danger.” Life Dynamics denies that its covert recording of the conversations is a violation of any state or federal laws (though 13 states targeted by the organization have anti-wiretapping laws), and is working diligently to spread its story throughout the press, starting with right-wing advocacy groups. The magazine Citizen, published by James Dobson’s Christian group Focus on the Family, says in a cover story that the tapes will “bring down Planned Parenthood.” And Neal Horsley’s far-right Nuremberg Files Web site features a story by Massachusetts attorney Greg Hession that outlines a strategy for “pro-life attorneys” to pursue in filing criminal and civil charges against Planned Parenthood. [Womens ENEws, 11/10/2002] (Horsley is an acknowledged advocate for the murder of abortion providers—see January 1997.) [Feminist Women's Health Center News, 2010] Evans says that if Life Dynamics achieves its stated objective of forcing medical providers to report all instances of teenagers’ sexual activity, “The system would be deluged,” and, in the absence of confidentiality, he predicts “teenagers would stop coming in.” [Womens ENEws, 11/10/2002]

HCA, the country’s largest for-profit hospital chain, announces that it has struck a deal with the Centers for Medicare & Medicaid Services (CMS) over unaudited Medicare and Medicaid billings.
The company—which paid more than $840 million in criminal fines, civil penalties, and damages in 2000 for fraudulent reportings to Medicare (see December 14, 2000), and which is still being investigated—will pay CMS $250 million to zero out its account with the agency. [Associated Press, 3/28/2002] But according to numerous government whistle-blowers, the amount is far too low. In a letter to the Department of Health and Human Services, Senator Charles E. Grassley (R-IA) will later accuse Medicare officials of “seeking to allow HCA to resolve more than $1 billion of liability to the Medicare program for only $250 million, based on little to no evidence supporting this low figure.” Even more troubling, notes the Senator, Medicare has agreed not to audit the company’s cost reports that have been piling up since 1997 when the agency stopped processing HCA bills because of the lawsuit. “One would expect a company with such a track record to be subjected to heightened scrutiny.… [Instead,] the Centers for Medicare and Medicaid Services is proposing to excuse HCA from an even routine review of thousands of Medicare cost reports,” Grassley writes. He says the deal is “too lenient.” John R. Phillips, one of the attorneys involved in the lawsuit against HCA, later says the deal was quietly arranged between HCA and CMS head Thomas A. Scully. “The $250 million was a total sellout by Scully, who totally negotiated it behind Justice’s back,” he says. [New York Times, 11/19/2002] Similarly, Grassley, in a June 25 letter to a Justice Department lawyer, says comments by Scully “have given me great concern that there is an active, ongoing effort underway to change or modify enforcement [on Medicare fraud] policy that in my view could significantly undermine the [law].” [Office of Senator Charles Grassley, 7/25/2002] Scully, during his confirmation hearings, had pledged he would “aggressively enforc[e] the fraud statutes” (see May 29, 2001).

After six months of negotiations, Merck and the FDA finally agree on the text for a warning about Vioxx’s cardiovascular side effects that will be added to the drug’s label. The FDA had wanted to include a clear message that Vioxx increases the risk of heart problems since the current version of the label includes no information about such risks. An excerpt from the FDA’s originally proposed text reads: “VIOXX should be used with caution in patients at risk of developing cardiovascular thrombotic events… . The risk of developing myocardial infarction in the VIGOR study was five-fold higher in patients treated with VIOXX 50 mg (0.5 percent) as compared to patients treated with naproxen (0.1 percent).…” The FDA also wanted to include a graph showing that the risk of heart problems increases with continued exposure to the drug. Merck objected to the FDA’s proposals. It insisted that a description of the cardiovascular risks be included in the “Precaution” section of the label, instead of the more severe “Warning” section, as proposed by the FDA. The company also wanted to include results from several disparate clinical studies that had been conducted prior to the drug’s release. These are the same tests that are cited in the “Cardiovascular Card” that Merck sales people show to doctors (see April 28, 2000). But the FDA objected, telling the company that the studies were “trials of different design, size, and duration, using different doses of VIOXX and different comparators” and therefore did not provide useful data for determining the drug’s cardiovascular risk. The FDA eventually concedes to several of Merck’s requests. The final text of the warning is included in the “Precaution” section of the label, as Merck wanted, and does not include the graph that had been requested by the FDA. The text of the cautionary statement is also watered down. The section summarizing the results of the VIGOR study (see March 2000) and two other studies states: “The significance of the cardiovascular findings from these 3 studies (VIGOR and 2 placebo-controlled studies) is unknown.” [Merck, 2001; US Food and Drug Administration, 1/30/2002 ; US Food and Drug Administration, 2005; Office of Representative Henry A. Waxman, 5/5/2005, pp. 16-19 ]

The US Supreme Court agrees to review NOW v. Scheidler (see June 1986, September 22, 1995, and March 29 - September 23, 1997) on the basis of two technical issues raised by the defendants. The Court refuses to hear the defendants’ challenge that the First Amendment was violated by earlier rulings or that speech is at issue. The Court will determine whether women victimized by the violence of the anti-abortion advocates in the lawsuit can be protected from future crimes by an injunction as opposed to merely recompensed for the losses caused by the actions (see July 16, 1999), and whether it was appropriate to use the Racketeer Influenced and Corrupt Organizations (RICO) Act against defendants who claim their actions were prompted by religious or moral motivations. [National Organization for Women, 9/2002] The Court will overturn the decision on technical grounds (see February 28, 2006).

The Journal of the American Dental Association publishes a study concluding that Bextra, a new drug manufactured by Pharmacia, offers relief to the acute pain patients feel after dental surgery. [Daniels et al., 2002] Just six months before, the FDA investigated the claim and found no evidence to support it. [New York Times, 11/22/2002] Bextra is only approved to treat pain caused by arthritis or painful menstrual cycles. [US Food and Drug Administration, 11/22/2002] During the three-month period following the article’s publication, Bextra sales increase by 60 percent. It is later learned that the authors of the article were not independent scientists, but rather employees of Scirex, a research company owned partially by Omnicom, one of the world’s largest advertising firms. When the New York Times asks three doctors to review the Scirex article, the doctors say its conclusions are not persuasive. “All three said that one of Scirex’s conclusions was insignificant: that one dose of Bextra worked longer than a single dose of a medicine containing oxycodone and acetaminophen, a combination often sold under the brand name Percocet. Patients rarely receive just one dose of that combination drug, the doctors said, because it wears off in four to six hours.” One of the doctors, Eric J. Topol, says the studies cited in the article make “a contrived comparison.” He notes that patients in the study had an average age of 23, which is not representative of the age group that would mostly likely use the drug. Judy Glova, a spokeswoman for Pharmacia, denies in a statement to the New York Times, that the article was an attempt to bypass the FDA regulation. And Pat Sloan of Omnicom insists the company has “nothing to do with the design of clinical studies.” [New York Times, 11/22/2002]

A federal appeals court in San Francisco rules that anti-abortion organizations who engage in the practice of distributing posters targeting abortion providers (see 1995 and After) are illegally threatening the lives and well-being of the people they are targeting. The 6-5 verdict also rules that Web sites such as The Nuremberg Files (see January 1997), which list doctors’ names and addresses and “lines out” the names of those doctors who are murdered, also threaten the lives of the named doctors. The defendants unsuccessfully claimed they were engaging in constitutionally protected political advocacy; the plaintiffs—four doctors and two health clinics—argued that the speech in question encouraged violence against abortion providers. The verdict overturns a previous three-judge ruling by the same court and reinstates a $109 million award for the plaintiffs. Writing for the majority, Judge Pamela Ann Rymer states: “While advocating violence is protected, threatening a person with violence is not.… This is not political hyperbole. They were a true threat.” Maria Vullo, a lawyer for the plaintiffs, says the essence of the decision is rejection of threatening speech. Of the “political advocacy” practiced by the defendants, Vullo says, “It’s really terrorism.” Christopher Ferrara, a lawyer for the defendants, says his clients will appeal the decision to the Supreme Court. “This is a threat case without any identifiable threat,” he says. “We’re found liable for the format we chose.” [New York Times, 5/17/2002] In spite of the verdict, the practice will continue (see January - April 2003, Fall 2009, and September 13, 2010).

Accused murderer James Kopp, an anti-abortion advocate who allegedly shot Dr. Barnett Slepian (see October 23, 1998), is extradited by French authorities (see March 29, 2001) to the US after the American government assures them that Kopp will not face the death penalty. French law precludes suspects being extradited to foreign nations if the possibility exists that they will be executed. Kopp retains lawyer Paul Cambria to defend him, but also retains lawyer Bruce Barket because Barket, like Kopp, has strong anti-abortion views and wants to make the defense about abortion (Cambria wants to defend Kopp strictly on the evidence). Barket will not be allowed to represent Kopp in federal court. [National Abortion Federation, 2010] Months later, Kopp will confess to the murder (see November 21, 2002). He will be found guilty several months later (see March 17-18, 2003).

The Office of Policy at the US Department of Health and Human Services (DHHS) releases a report concluding that the US government should not impose price caps on prescription drugs. According to the report, doing so “could put the future of medical innovation at risk and may retard advances in treatment.” [US Department of Health and Human Services, 7/2002, pp. 2 ] The deputy assistant secretary of the division, Ann-Marie Lynch, had used the same argument when she was a drug industry lobbyist (see June 2001) fighting against congressional efforts to cap drug prices. [Denver Post, 5/23/2004] Critics of the report say its conclusions are contradicted by the experiences of other countries that have remained innovative despite price controls. DHHS officials “haven’t taken as seriously their job of making medicines affordable to all Americans,” says Gail Shearer, director of health policy analysis for Consumers Union. According to critics, the report plays a role in the passing of Bush’s Medicare drug plan that prohibits the government from using its buying power to negotiate lower prices from the drug companies.

Pfizer attorney Malcolm Wheeler calls FDA chief counsel Daniel E. Troy requesting that the agency intervene in a lawsuit filed against the company. The lawsuit alleges that Zoloft, an antidepressant drug manufactured by Pfizer, caused Victor Motus of California to kill himself on November 12, 1998. It also says that the drug company should have warned physicians that Zoloft might cause suicidal thoughts in some people. On September 3, the FDA files a brief stating that the agency’s scientists have found no evidence that antidepressants cause suicidal thoughts. Furthermore, the FDA argues, if Pfizer had warned doctors of such a link, it would have been a violation of the law because all warnings must first be vetted by the FDA. According to Troy, the agency has “absolute control over the label.” This position, notes one of the plaintiff attorneys in the Pfizer case, contradicts arguments that Troy made when he was practicing in the private sector. Before he had argued that the agency’s rulings were arbitrary and capricious. [Boston Globe, 12/22/2002]

The FDA begins blocking consumer lawsuits against drug manufacturers and asking attorneys working for drug companies to notify the agency of such lawsuits so it can intervene on their behalf. The agency’s chief counsel, Daniel E. Troy, asserts that consumers cannot sue drug companies over drugs that the agency has approved because FDA decisions on the safety of drugs are absolute and cannot be challenged by any state court. According to the FDA, allowing such lawsuits to proceed would “undermine public health” and disrupt the FDA’s regulation of drugs by encouraging “lay judges and juries to second-guess” FDA experts. Furthermore, the Bush administration argues, lawsuits “can harm the public health” because they may cause companies to remove products from the market or to overstate the risks, possibly resulting in the “underutilization of beneficial treatments.” The policy of prohibiting consumers from suing drug companies, according to the FDA, is meant to protect consumers. This policy differs sharply with the agency’s past practice, which allowed states to adopt stricter standards. But the FDA’s new claim that it has absolute jurisdiction over the question of drug safety preempts state involvement in the regulation over drugs. [New York Times, 7/25/2004] The Boston Globe notes that this policy allows the White House to “use its administrative and legal powers to change the regulatory terrain without taking the often arduous course of asking Congress to change the law.” [Boston Globe, 12/22/2002; New York Times, 7/25/2004]

Anti-abortion advocate James Kopp, accused of murdering Dr. Barnett Slepian (see October 23, 1998), confesses to the crime during an interview with the Buffalo News. “I did it, and I’m admitting it,” he says. “But I never, ever intended for Dr. Slepian to die.… I regret that he died. I aimed at his shoulder.” Kopp, who for months has vehemently denied any involvement in Slepian’s death, is accompanied by his lawyer, Bruce Barket. Both Kopp and Barket intend to make their legal defense about abortion, and will attempt to claim moral justification for the murder due to Kopp’s anti-abortion views. Of other abortion providers, Kopp says: “They’re still in danger, absolutely. I’m not the first, and I probably won’t be the last.… To pick up a gun and aim it at another human being, and to fire, it’s not a human thing to do. It’s not nice. It’s not pleasant. It’s gory, it’s bloody. It overcomes every human instinct. The only thing that would be worse, to me, would be to do nothing, and to allow abortions to continue.” Kopp claims he wants to set the record straight for the sake of his supporters who were publicly proclaiming his innocence and saying the FBI had framed him. Kopp adds that he selected Slepian’s name from the phone book, and that he also cased the homes of several other physicians before deciding that Slepian’s was the most vulnerable due to a window in the back that faced the woods. After his confession, prosecutors charge Kopp with an additional charge of reckless murder with depraved indifference to human life. [Associated Press, 11/21/2002; Buffalo News, 11/22/2002; National Abortion Federation, 2010]Ends Claims that Kopp Innocent, Framed by Police - In January 2003, the magazine Catholic Insight will observe: “With this admission, Kopp knocked the feet out from under those pro-life supporters who had suggested that he couldn’t have committed the crime because he was a pacifist, had poor eyesight, was a poor marksman, or was being framed by the police. Pro-life advocates who earlier had condemned the shootings as unacceptable acts of violence could take solace in the fact that Kopp made it clear he acted alone in the Slepian shooting and that no one in the Buffalo pro-life community had suggested Slepian as a target.” [Catholic Insight, 1/1/2003]Anti-Abortion Advocates Condemn Kopp's Shooting but Welcome Trial as Platform for Debating Abortion - The Reverend Paul Schenck, an anti-abortion advocate who has led numerous protests and has been arrested for blockading abortion clinics, says of Kopp: “James Kopp has admitted to being a cold-blooded killer, a vigilante who acted as judge, jury, and executioner. In what he did, he undermined the whole moral philosophy of the pro-life movement, which views every human life as intrinsically valuable and created in God’s image. He should fade into ignimony after being utterly rejected by all people of conscience. May God have mercy on his soul.” [US Newswire, 11/21/2002] Bishop Henry Mansell, a local anti-abortion leader, says while he disapproves of Kopp’s action and the use of violence against abortion providers, he welcomes the use of Kopp’s trial to create a platform for an abortion debate. “We don’t believe the end justifies the means,” Mansell says. “But given a trial, I hope there would be a discussion and an exploration of the issues in depth.” Pro-choice lawyer Glenn Murray disagrees, saying, “I would hate to think that those who want a referendum on abortion would exploit an act of terrorism.” [Buffalo News, 11/22/2002] “Kopp is an extremist, a terrorist, a self-confessed murderer plain and simple, so his jailhouse confession is nothing more than a cynical attempt to manipulate us all through the media,” says Gloria Feldt, president of Planned Parenthood, a pro-choice organization. The Reverend Philip “Flip” Benham, director of the anti-abortion organization Operation Save America (formerly Operation Rescue), says Kopp “betrayed the pro-life movement, unborn children, and the Lord he proclaims to serve. You never overcome the problem of murder by murdering people.” [Associated Press, 11/21/2002]Kopp Will Be Found Guilty - Kopp will be found guilty of Slepian’s murder (see March 17-18, 2003).

ALL president Julie Brown points to her organization’s ‘Deadly Dozen’ poster. [Source: Life Magazine]A new advertising and poster campaign attacking pro-choice Catholic senators harks back to the dangerous “Deadly Dozen” campaign of 1995 (see 1995 and After), according to pro-choice advocates. The 1995 advertising and poster campaign targeted over a dozen health care and abortion providers, usually listing their names, addresses, and telephone numbers. The new campaign is by the American Life League (ALL—see 1979), an anti-abortion organization centered in Stafford, Virginia. Both the 1995 and the current campaigns feature “Old West” themed posters. ALL’s posters provide photographs of a dozen pro-choice US senators under the announcement, “Wanted For Fradulently Claiming Catholic Faith”; like the earlier campaign, the senators are branded as “The Deadly Dozen.” The senators pictured include Ted Kennedy (D-MA), Tom Daschle (D-SD), John Kerry (D-MA), and Barbara Mikulski (D-MD). The campaign calls for bishops to refuse communion to the senators. Vicki Saporta of the National Abortion Federation says she is appalled by ALL’s choice of slogans. “This type of language is associated with violence,” she says. “Seven people lost their lives as a result of this type of verbiage. What is the American Life League thinking?” The new ad campaign is running in selected newspapers, including the Washington Times and The Wanderer, a weekly Catholic newspaper in Massachusetts. A new round of posters is planned, targeting, among others, Governor Gray Davis (D-CA) of California and other California pro-choice lawmakers, according to ALL official Joseph Giganti. Giganti says ALL is opposed to violence and calls comparisons between his organization’s campaign and the 1995 campaign “reckless and careless.… Our ads don’t refer to being wanted dead or alive; it is referencing the fact abortion kills. We are simply saying, if you are in fact Catholic, how can you continue to support abortion?” Giganti blames pro-choice groups for “purposely… misinterpret[ing]” the campaign and using it “as a stepping stone to voice their own opinions.” At least 11 Catholic diocesan newspapers have turned down the ads. “The kind of advertising they are doing is inflammatory,” says Frances Kissling, president of Catholics for a Free Choice. “It could incite someone, set someone off. But the more dominant issue is that they will disgust people. This ad will only reinforce pro-choice. People who have mixed feelings about abortion, people who are moderates will be turned off by the advertisements.” A spokesman for one targeted senator, Christopher Dodd (D-CT), says of the campaign: “There is no place in America for personal attacks on those with whom one disagrees. Ultimately, Senator Dodd’s religious views are a personal matter between him and God.” [Life, 1/22/2003; Womens ENews, 4/21/2003]

After reviewing results of clinical study 3014 for the antibiotic Ketek, an FDA advisory panel recommends that the drug be approved. [Aventis, 1/9/2003] The panel makes the decision completely unaware that the FDA had discovered problems with the study only a few months before. [ABC, 1/14/2006; Wall Street Journal, 5/1/2006 ] In October, an FDA examiner found that some doctors were reporting fraudulent results. For example, some doctors had failed to record the data properly while others had invited patients into the study who did not meet the necessary qualifications. In one case, several patients who were enrolled in the study were not actually taking the drug (see October 2001-Fall 2002).

The anti-abortion organization Operation Rescue releases a statement from its director, the Reverend Philip “Flip” Benham, criticizing a rally held in Buffalo, New York, to memorialize James Kopp, the confessed murderer of abortion provider Dr. Barnett Slepian (see October 23, 1998 and November 21, 2002). Benham accuses pro-choice advocates of participating in the “murder” of “over 45 million children killed by ‘legalized’ abortion,” and says: “Those who advocate murdering abortionists are going to be given a national platform from which to spew their vitriolic poison. How sad!” Benham denies that Operation Rescue has ever advocated or supported violence against abortion providers (see August 1988, January 7, 1998, and April 20, 1998), adding that his organization has “totally debunked” the idea that “murdering abortionists is somehow justifiable biblically,” and blames “the media” for propagating “this poisonous lie” that anti-abortion advocates espouse violence in order to “divert our attention from the true holocaust savaging our nation, and paint every Christian who lives out his faith at an abortion mill as a wild-eyed lunatic, bent on doing violence.” [Operation Save America, 1/13/2003]

Aventis announces that the FDA has again declined to approve the company’s antibiotic drug Ketek, citing the need for additional analyses and information pertaining to Study 3014 (see October 2001-Fall 2002). [Aventis, 1/27/2003]

Anti-abortion activist Joseph Scheidler (see 1980, 1985, June 1986, April 20, 1998, October 2, 2001, and February 28, 2006) claims to have renounced the violent tactics that made him such a notorious figure of the anti-abortion, or pro-life, movement (see 1986 and March 26, 1986). Scheidler, 75, a former Benedictine monk and newspaper reporter who lives in Chicago, says he now favors peaceful marches on abortion clinics, the display of posters with graphic depictions of aborted fetuses, and what he calls “counseling” of women seeking abortions. “Obstruction—that’s over,” Scheidler says. “I was in some of those demonstrations, but I could see that was not going to be the real way. You’ve got to convert people away from abortion. You don’t just keep them out of the clinics. They just arrest you and you’re gone, and they go back in. I always hated it when the day was done, and they were all going back to the clinic and we were sitting in a [police] wagon.” He adds: “Nothing’s going to change in what we do. I haven’t stopped doing anything that I thought was effective. What will change is I think more people will come out.” [Chicago Sun-Times, 2/27/2003]

A handcuffed James Kopp is escorted into an Erie County courtroom to face trial for murdering Dr. Barnett Slepian. [Source: Getty Images]James Kopp, the anti-abortion advocate who has confessed to murdering abortion provider Dr. Barnett Slepian (see October 23, 1998 and November 21, 2002), is tried for the murder. Kopp has agreed to a bench trial in lieu of a jury; both the defense and prosecution have already agreed to a number of basic facts stipulated about the case. Defense attorney Bruce Barket argues that Kopp should be acquitted because of his moral belief that force is necessary to stop abortions, and because he did not intend to kill Slepian, but only wound him. Prosecutor Joseph Marusak counters by arguing that every step Kopp took in planning for the attack, including his choice of weapon and the use of aliases in buying the rifle, pointed to an intention to kill. After less than two days of trial, Judge Michael D’Amico finds Kopp guilty of second-degree murder. Kopp will be sentenced to 25 years to life in prison. [Associated Press, 3/18/2003; National Abortion Federation, 2010] Kopp is allowed to read a long statement explicating his anti-abortion views into the court record. [Buffalo News, 1/7/2007] Pro-choice organization Planned Parenthood says of Kopp’s conviction: “The conviction of confessed terrorist and murderer James Kopp is a triumph for justice. Our thoughts are with Dr. Slepian’s family and community. James Kopp’s horrendous crime is a painful reminder of the threat posed by extremists who will go to any lengths to impose their ideology on others. Planned Parenthood and America’s pro-choice majority will not tolerate anti-choice terrorists and their limitless hostility toward reproductive health care providers and the women they bravely serve. We hope the outcome of the Kopp trial will dissuade other anti-choice extremists from further harassment and violence. Planned Parenthood is committed to protecting our patients, staff, and volunteers and to ensuring that those who threaten them are brought to justice.” [Planned Parenthood, 3/18/2003] The National Abortion Federation’s Vicki Saporta says in a statement: “Unfortunately, there are many anti-choice extremists who believe that it is justifiable to kill doctors because they provide women with safe and legal abortion care. The Army of God, of which Kopp is a member (see 1982), supports the use of force to end abortion. [V]iolence against abortion providers is never acceptable or justified.… One trend we have documented is that when one murderer is brought to justice another one is quickly recruited to become the next assassin. Kopp’s trial must not lead to another series of assassination attempts directed at physicians who perform abortions. We, therefore, continue to urge law enforcement to remain especially vigilant in enforcing the law and prosecuting those who would use violence to advance their own personal, political agendas.” [National Abortion Federation, 3/17/2003]

Thomas A. Scully, administrator of the Centers for Medicare & Medicaid Services (CMS), warns Richard S. Foster, the agency’s top expert on Medicare costs, that he will be fired if he responds to Congress’s request for a cost estimate on the drug plan favored by the administration. Foster estimates that the plan will cost $534 billion over the next 10 years. This amount is roughly a third more than the $400 billion estimate that was provided to legislators by the Congressional Budget Office. The White House knows about Foster’s cost estimate but fears that if Congress obtains this information, it will not pass the drug plan. Several conservative House Republicans have said they will not vote for the bill if it exceeds $400 billion. Foster’s estimates are shared with Doug Badger, the president’s special assistant for health policy, and with James C. Capretta, associate director of the White House Office of Management and Budget. Scully instructs Foster that all cost estimates must first be submitted to him so he can decide whether they should be released. “More than once, Tom said he was just following orders,” Foster later tells the Washington Post, adding that he suspects the orders were coming directly from the White House, probably from Badger. On other occasions, when Foster is talking to lawmakers over the phone, White House officials are routinely on the line monitoring his comments and in some instances they instruct Foster not to respond to lawmakers’ questions, according to an unnamed congressional Democratic aide. It is not until January 2004, after the drug bill is passed, that the White House finally releases Foster’s estimates. [Knight Ridder, 3/12/2004; Washington Post, 3/13/2004; New York Times, 3/25/2004; US Department of Health and Human Services, 7/6/2004 ; New York Times, 7/7/2004] Several Republicans later say they would not have voted for the program had they known its true cost. [Savage, 2007, pp. 116]

At the same time top Medicare official Thomas A. Scully is working with Congress to draft new Medicare legislation, he is looking for a private sector job that will pay him to advise clients affected by the very same Medicare program he is helping to draft. The fact that Scully’s job search is taking place at the same time he is working on legislation, raises concerns that his contributions to the bill are potentially being influenced by his own private interests. Scully insists however that he is complying with all federal ethics regulations and says he has a waiver from the department’s general counsel permitting him to seek work in the private sector. By December he has narrowed his list of prospective employers to five companies: Alston & Bird; Baker, Donelson, Bearman, Caldwell & Berkowitz; Ropes & Gray; Welsh, Carson, Anderson & Stowe; and Texas Pacific Group. All of the companies have clients in the health care industry. Scully, who made $675,000 a year as a lobbyist before taking his current position in the government at $134,000 a year, is expected to make a hefty salary in the private sector with his insider knowledge of the new Medicare program. “His exhaustive knowledge of the Medicare program and the intricacies of the legislation, approved by Congress last week, would make him a prize catch for any law firm or private equity firm,” notes the New York Times. Scully will resign on December 16, less than a month after Congress passes the Medicare bill. [Washington Post, 12/3/2003; New York Times, 12/3/2003]

HCA Inc. and the US Justice Department sign a settlement agreement, resolving allegations that the company paid kickbacks to physicians and submitted false cost reports and fraudulent bills to Medicare, Medicaid, and other federal health programs. Under the terms of the agreement, HCA, the country’s largest for-profit hospital chain, will pay the US government $631 million in civil penalties and damages. Additionally, under a separate agreement that was negotiated more than a year ago, HCA will pay the Centers for Medicare and Medicaid Services (CMS) $250 million to resolve “outstanding cost report issues.” Critics of that settlement have alleged that the CMS head—a former lobbyist for the hospital industry—cut the deal behind the Justice Department’s back saving HCA several hundred million dollars (see March 28, 2002-November 2002). [CBS News, 12/18/2002; Washington Post, 12/19/2002; US Department of Justice, 6/26/2003; Nashville Business Journal, 6/26/2003; New York Times, 6/27/2003] These amounts, when combined with the $840 million settlement reached in December of 2000 (see December 14, 2000), make this the government’s single largest fraud settlement in US history. The $1.7 billion settlement concludes a nine-year investigation that began when whistle-blower James Alderson, a former chief financial officer of one of its former hospitals, filed a lawsuit alleging that the company’s cost reports to the government were fraudulent. During the course of the investigation, authorities discovered a second set of books marked “confidential,” revealing that the company had inflated reimbursable costs billed to government health programs. [Phillips & Cohen, 12/18/2002; New York Times, 12/18/2002]

FDA chief counsel Daniel E. Troy intervenes in a lawsuit against Glaxo SmithKline, the manufacturer of the drug Paxil. The FDA says it disagrees with the judge’s temporary order that the phrase “not habit-forming” be removed from the company’s advertisements promoting Paxil. The plaintiffs in the case alleged that the phrase is misleading because they experienced withdrawal symptoms after they stopped taking the drug. The judge agreed saying, “It is difficult to imagine that the FDA would object to the removal of the reference that ‘Paxil is not habit-forming.’” But Troy does object. The FDA, taking the side of Glaxo SmithKline, says the product is not habit-forming and contend that the symptoms experienced by patients were not withdrawal symptoms, but rather symptoms of “discontinuation syndrome.” According to Troy, the FDA has absolute authority on the content of drug labels. Following the FDA’s intervention, the judge lifts her temporary order. [Boston Globe, 12/22/2002]

A study conducted by Harvard University and the Canadian Institute for Health Information finds that administrative costs in America’s health care system are almost twice that of Canada. The study, published in the New England Journal of Medicine, reports that the US health bureaucracy consumes 31 percent of total health care spending. By comparison, Canada’s administrative expenses amount to only 16.7 percent. Steffie Woolhandler of Harvard, who led the team, says if the US were to adopt a single-payer health care system like Canada, the funds saved would be enough to provide insurance for the more than 41 million uninsured Americans. [Woolhandler, Campbell, and Himmelstein, 2003; Toronto Star, 8/21/2003]

FDA medical officer Andrew D. Mosholder finds evidence that antidepressant drugs such as Paxil, Zoloft, and Effexor may increase the risk of suicidal thoughts in children. Agency officials praise his work but express a lack of confidence in the data. The FDA takes no action. [Washington Post, 9/24/2004]

Paul Hill, a former minister convicted of the murder of Dr. John Britton and bodyguard James Barrett (see July 29, 1994), is put to death by lethal injection. Hill is the first person executed in the US for anti-abortion violence. Florida Governor Jeb Bush (R-FL) ignores calls by death penalty opponents and threats from anti-abortion activists to stop the execution, saying he will not be “bullied” into stopping Hill’s execution. Hill dies via a lethal injection. Florida abortion clinics are on heightened alert for reprisals and attacks; several clinic officials have received death threats in recent weeks. Hill has never contested his execution, instead insisting that he merely followed God’s orders in killing Britton and Barrett. He has maintained that God will forgive him for the murders. “I expect a great reward in heaven,” he said just days before his execution. “I am looking forward to glory.” Hill has called for others to use violence to prevent abortions. Many extremist anti-abortion organizations openly proclaim Hill as a martyr for their cause, while more mainstream anti-abortion organizations have denounced Hill’s use of violence. [Fox News, 9/3/2003; CBS News, 4/19/2007] Father David C. Trosch, a staunch supporter of Hill, will write a eulogy of sorts for him three days after the execution. Trosch was present during at least one day of court proceedings, and will complain that Hill was not allowed “to speak to the jury regarding his motive for killing an abortion provider and an assistant.” According to Trosch, “It was a justifiable deed as he was defending innocent pre-born, tiny, perfectly formed human beings, each carrying a fully formed human spirit, given to them by God, at their conception.” Trosch will write that he is more saddened by Hill’s execution than he was by the loss of any number of his family members, including his parents, wife, and children. [David C. Trosch, 9/6/2003]

President Bush signs a bill into law banning so-called “partial-birth abortions.” A similar bill was vetoed by then-President Clinton in 1996 (see April 1996). The bill signing is part of a ceremony of abortion opposition featuring some 400 lawmakers and anti-abortion advocates. The new law, known as the Partial Birth Abortion Ban Act, is the first time the federal goverment has banned an abortion procedure since the 1973 Roe v. Wade decision legalized abortions (see January 22, 1973). A federal judge in Nebraska has already said the law may be unconstitutional, and many observers expect it to be challenged. [CBS News, 4/19/2007] Three years later, the Supreme Court will uphold the law (see April 17, 2007).

Britain’s Department of Health advises doctors treating depressed children to prescribe only Prozac. Other antidepressants like Zoloft, Paxil, Luvox, Effexor, Celexa, and Lexapro should be avoided, it warns, because of a potential link between these drugs and suicidal and hostile behavior. [BBC, 12/10/2003; New York Times, 12/16/2003] The FDA takes no action in the US, and continues to sit on a study by one of its own scientists (see September 2003) that links the drugs to suicidal thoughts in children. [Washington Post, 9/24/2004]

Thomas A. Scully resigns as head of the Centers for Medicare & Medicaid Services (CMS)(formerly called the Health Care Financing Administration (HCFA)). [Washington Post, 12/3/2003] For the last six months Scully, a former lobbyist for the health care industry, has been shopping around for a job in the private sector hoping to find a firm that would hire him to advise clients affected by the new Medicare program that he helped draft (see June-December 2003). Shortly after resigning, Scully is hired by Alston & Bird LLP to help the law firm build a health practice in their Washington office. He also lands a second part-time job with Welsh, Carson, Anderson & Stowe, a New York investment firm specializing in telecommunications and health care. [Washington Post, 1/14/2004]

In January 2004, an FDA safety officer determines from analysis of adverse event reports that there may be a link between sudden blindness and the impotency drug Viagra. She recommends that the agency warn doctors and patients about the drug’s possible side effect. FDA staffers generally agree that Viagra’s label needs to be updated with a warning. Two months later, a formal draft safety “consult” on the potential Viagra-blindness link is submitted, followed by a final report in April. The FDA approaches Pfizer, the maker of the drug, but the company “resist[s] the FDA’s initial request to update the Viagra label to include information about the NAION risks,” according to a letter that is later sent to the FDA by Senator Charles E. Grassley. The FDA does not issue a public notice or propose a change to the drug’s label until May 2005 when a study published in the Journal of Neuro-Ophthalmology reports seven cases of men experiencing sudden blindness within 36 hours of taking Viagra. [New York Times, 6/1/2005]

Russell Katz, director of the FDA’s division of neuropharmacological drug products, informs medical officer Andrew Mosholder that he will not be permitted to present his report on the suicidal side effects of Paxil, Zoloft, and certain other antidepressants. Mosholder—who believes the drugs may increase suicidal tendencies in children (see September 2003)—was scheduled to report his findings at an FDA advisory hearing on February 2. Katz reportedly tells Mosholder his report is biased. When the San Francisco Chronicle asks about this decision, Anne Trontell, deputy director of the agency’s Office of Drug Safety, says Mosholder can’t present the report because it has not yet been “finalized.” [San Francisco Chronicle, 2/1/2004]

The National Academy of Sciences issues a report calling for universal health insurance coverage by 2010. “It is time for our nation to extend coverage to everyone,” the report says. “Universal insurance coverage is an important and achievable goal for the country.” The report was drafted by a panel of 15 experts and is the product of three years of work. Sampling of report's conclusions - People without insurance receive about half the medical care of those who have it. Consequently, they are on average sicker and tend to die sooner. Roughly 18,000 people die each year because they do not have insurance. In 2001, only half of uninsured children in the US visited a physician during 2001, compared with three-quarters of privately insured children. In 2001, taxpayers spent roughly $30 billion in unreimbursed medical care for uninsured Americans. The poorer health and premature deaths of uninsured people cost taxpayers between $65 billion to $130 billion a year. Reaction in US government - Republican Senate majority leader Bill Frist of Tennessee—whose family owns HCA Inc., the largest for-profit hospital chain in the US—expresses concern that “the report may not focus enough on the reasons why health care costs continue to rise and how to pay for any reform.” Democratic Senator Tom Daschle of South Dakota supports the call. “It’s doable,” he says. “It’s essential. This is, I believe, the single most important domestic issue facing our country.” Tommy G. Thompson, secretary of health and human services, tells reporters the proposal is “not realistic.” [Institute of Medicine, 2004; National Academies, 1/14/2004; New York Times, 1/15/2004]

The FDA’s Division of Scientific Investigations says in a memo that Aventis’s clinical study for the drug Ketek, study 3014 (see October 2001-Fall 2002), “uniformly failed to detect data integrity problems when they clearly existed.” The report notes that doctors participating in the study failed to comply with FDA regulations and were found to have engaged in “multiple instances of fraud.” [Wall Street Journal, 5/1/2006 ]

The FDA approves the drug Ketek for treatment of chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia in patients age 18 and older. [Aventis, 4/1/2004] The approval decision is made despite evidence that a 2001-2002 clinical trial for the drug, study 3014, was replete with fraudulent data (see October 2001-Fall 2002). The FDA says the approval is based on data submitted in 2000, other studies, and the drug’s safety record overseas where the drug has been in use for several years. [Wall Street Journal, 5/1/2006 ]

The Food and Drug Administration (FDA) announces that it will not permit pharmacies to sell the emergency contraception drug “Plan B” without a prescription. The drug is a “morning-after” birth-control drug that prevents fertilization and the implantation of the embryo. The agency explains to the manufacturer of the drug, Barr Pharmaceuticals, that the government is worried about the possibility that teenaged girls might not understand how to correctly use the drug without a doctor’s advice. The FDA’s decision is in direct contradiction of a federal advisory panel’s 23-4 decision to recommend approving the drug for over-the-counter sales, including to teenagers, without a doctor’s approval. The FDA’s staff recommended that the agency follow the panel’s recommendation. In 2007, author and reporter Charlie Savage will write, “Normally, agencies such as the FDA base their decisions on the information provided by their expert advisory panels—but, strangely, not this time.” A spokesman for the presidential campaign of John Kerry (D-MA) says: “By overruling a recommendation by an independent FDA review board, the White House is putting its own political interests ahead of sound medical policies that have broad support. This White House is more interested in appealing to its electoral base than it is in protecting women’s health.” James Trussell, director of the office of population research at Princeton University and a member of the advisory board, says, “The White House has now taken over the FDA.” Numerous women’s groups accuse the FDA’s political appointees of overruling the experts in order to please social conservatives who believe that the “Plan B” drug encourages promiscuity and is a form of abortion. In the following months, a lawsuit will be filed to have the FDA’s decision overturned (see January 21, 2005 and After). [New York Times, 3/7/2004; Savage, 2007, pp. 300-301]

Three separate federal courts rule that the federal ban on so-called “partial-birth abortions” (see November 5, 2003) is unconstitutional. One judge rules that the law illegally infringes on a woman’s right to choose. A second and third rule that the law must contain a provision excepting such a procedure in the case of a danger to the mother’s life or health. The case will be appealed to the Supreme Court (see April 17, 2007). [CBS News, 4/19/2007]

FDA scientist David Graham has analyzed data on 1.4 million Kaiser Permanente patients who took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. Based on his findings, Graham believes there have been more than 27,000 heart attacks and sudden cardiac deaths in the US that would not have occurred had those patients been prescribed Celebrex instead of Vioxx. [Washington Post, 10/8/2004] When the FDA reviews a summary of his study, which Graham will present in France on August 25 (see August 25, 2004), his conclusion triggers “an explosive response from the Office of New Drugs.” Graham later tells Congress, “I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.” [US Congress, 11/18/2004 ] In an August 12 e-mail, John Jenkins, director of the Office of New Drugs, suggests “watering down” the report’s conclusions because the FDA is “not contemplating” a warning against high-doses of Vioxx. In response, Graham says, “I’ve gone about as far as I can without compromising my deeply-held conclusions about this safety question.” In another e-mail, a different top official expresses concern about how the report might impact Merck. The person writes that the company should be warned beforehand “so they can be prepared for [the] extensive media attention that this will likely provoke.” [Wall Street Journal, 10/8/2004; Washington Post, 10/8/2004]

David Graham, associate science director for the FDA’s Office of Drug Safety, presents the findings of a study on Vioxx in a poster exhibit at an international medical conference in Bordeaux, France. According to Graham’s research, thousands of Americans have died from taking the drug. In his study, he analyzed data on 1.4 million Kaiser Permanente patients that took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. According to Graham’s analysis of the data, the risk of having a heart attack or dying from heart problems is 3.2 times higher for Vioxx patients than people who do not use painkillers, and twice as high for those using Celebrex. Based on these figures, Graham estimates that more than 27,000 Americans have had heart attacks or died from sudden cardiac deaths as a result of taking Vioxx instead of Celebrex. In response to Graham’s study, Merck, the maker of Vioxx, issues a statement insisting that its drug is safe. Alise Reicin, vice president of clinical research at Merck, claims that numerous studies comparing the drug to a dummy pill found “no difference in the risk of having a serious cardiovascular event.” FDA spokeswoman Laura Alvey says the FDA has no plans to ban the drug. “Removing the drug from the market is not on the table,” she says. [Associated Press, 8/26/2004] Prior to the event, FDA officials had pressured him to water down his conclusions (see Mid-August 2004).

At a meeting attended by several officials and managers of the reviewing office of the FDA, David Graham, who recently presented a paper linking Vioxx to the deaths of more than 27,000 Americans, is asked by the director of the FDA reviewing office why he “even thought to study Vioxx and heart attacks because FDA had made its labeling change and nothing more needed to be done,” according to Graham’s later testimony to Congress. Also during the meeting, a senior manager from the Office of Drug Safety refers to Graham’s study as “a scientific rumor.” [US Congress, 11/18/2004 ]

Merck voluntarily withdraws Vioxx from the market after a long term colon-polyp prevention study, called APPROVe, appears to show that the drug doubles the risk of heart attacks or strokes when taken for 18 months or longer. [Merck, 9/30/2004 ] Acting FDA Commissioner Dr. Lester M. Crawford praises Merck for “promptly reporting these finding” to the FDA. [US Food and Drug Administration, 9/30/2004] An estimated 107 million people have used Vioxx since it was approved in 1998. A paper by FDA scientist David Graham, published in the British medical journal Lancet, will later suggest that 88,000-140,000 Americans may have suffered serious coronary heart disease as a result of taking the drug.
(see January 25, 2005)

Raymond Gilmartin, Merck’s chairman and chief executive officer tells the Boston Globe he was “stunned” when he learned a Merck clinical trial had confirmed that Vioxx increased the risk of heart attacks and strokes. “It was totally out of the blue.… This was totally unexpected.” [Boston Globe, 10/9/2004]

David Graham, associate science director for the FDA’s Office of Drug Safety, appears before the Senate Committee on Finance to testify on the agency’s ability to protect the American public from harmful drugs. Graham, a twenty-year veteran of the agency, tells the committee that “the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.” Graham was an early critic of Vioxx, a painkiller that was recalled in September (see September 30, 2004) because of its link to heart problems. Graham recounts how in August (see Mid-August 2004), the FDA tried to suppress a study he led which found that “nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx.” He says the study’s findings were “extremely conservative” and that “a more realistic and likely… estimate ranges from 88,000 to 139,000 Americans” of which “30-40 percent [or 26,400-55,600] probably died.” He notes that this figure is the “rough equivalent of 500 to 900 aircraft dropping from the sky… [or] 2-4 aircraft every week, week in and week out, for the past 5 years.” [US Congress, 11/18/2004 ] The remainder of Graham’s testimony focuses on problems within the FDA’s Office of Drug Safety (ODS). He makes the following points: The Office of New Drugs (ONS), which approves all new drugs, is the same division that is responsible for taking regulatory action against those drugs after they have been released on the market. This is an inherent conflict of interest, he notes, because when a problem arises, recognizing it would require the ONS to acknowledge that it had made a mistake. Instead, the office’s “immediate reaction [to a problem] is almost always one of denial, rejection, and heat.” [US Congress, 11/18/2004 ] The Office of Drug Safety (ODS) is subordinate to the Office of New Drugs, and consequently the management of the former sees its mission as pleasing the latter. [US Congress, 11/18/2004 ] The culture of the FDA’s Center for Drug Evaluation and Research (CDER) “views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards, and disrespects drug safety.” [US Congress, 11/18/2004 ] The Office of New Drugs refuses to take regulatory action on any drug unless it can be shown with 95 percent or greater certainty that it is unsafe. However “to demonstrate a safety problem with 95 percent certainty, extremely large studies are often needed… [and] those large studies cannot be done.” Graham suggests the 95 percent rule makes as much sense as a person with a 100-chamber pistol loaded with 90 bullets saying that the gun is safe. “Because there is only a 90 percent chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.” [US Congress, 11/18/2004 ]

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